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Taxotere
Docetaxel
$140.00
20mg/1mL · 1 vial
Generic· By Seacross
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20mg/1mL
20mg/2mL
80mg/4mL
80mg/8mL
160mg/8mL
160mg/16mL
FDA boxed warningToxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2.
Avoid the use of docetaxel injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase > 1.5 x ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel injection.
Do not administer docetaxel injection to patients with neutrophil counts of < 1500 cells/mm 3. Monitor blood counts frequently as neutropenia may be severe and result in infection.
Do not administer docetaxel injection to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel injection infusion and administration of appropriate therapy.
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m 2
Avoid use of docetaxel injection if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle
Do not administer docetaxel injection to patients with neutrophil counts < 1500 cells/mm 3. Obtain frequent blood counts to monitor for neutropenia
Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel injection and administration of appropriate therapy
Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80
Severe fluid retention may occur despite dexamethasone
About Taxotere
Overview
Taxotere contains docetaxel, an anticancer medicine supplied in a vial. It is used for certain breast and non-small cell lung cancers, metastatic castration-resistant prostate cancer, advanced stomach cancer including cancer at the junction with the oesophagus, and locally advanced squamous cell head and neck cancer. Depending on the cancer and previous treatment, it is used alone or with other medicines. It works by disrupting structures inside cells called microtubules, preventing cells from dividing normally.
What it treats
- Breast cancer: locally advanced or metastatic disease after chemotherapy failure; or with doxorubicin and cyclophosphamide as additional treatment for operable cancer involving lymph nodes. - Non-small cell lung cancer: locally advanced or metastatic disease after platinum-based treatment failure; or with cisplatin for previously untreated disease that is locally advanced and cannot be surgically removed, or has spread. - Metastatic castration-resistant prostate cancer, with prednisone. - Previously untreated advanced gastric adenocarcinoma, including cancer at the junction of the stomach and oesophagus, with cisplatin and fluorouracil. - Locally advanced squamous cell cancer of the head and neck, with cisplatin and fluorouracil as initial treatment.
Safety information
Side effects
Common side effects include infections; low white blood cells, sometimes with fever; anemia; low platelets; allergic reactions; numbness, tingling or nerve pain; changes in taste; shortness of breath; constipation; reduced appetite; nail changes; fluid retention; weakness; pain; nausea, diarrhea or vomiting; inflammation of the mouth or digestive tract; hair loss; skin reactions; and muscle pain. How often these occur varies by the condition being treated. Contact a doctor promptly for fever or signs of infection, allergic reactions, shortness of breath, swelling, severe diarrhea or abdominal pain, severe weakness, worsening numbness or nerve pain, or changes in vision. Serious risks include life-threatening treatment toxicity, liver problems, blood cell abnormalities, bowel inflammation, severe allergic reactions and fluid retention. Severe skin reactions may involve redness and swelling of the hands or feet followed by peeling. Swelling in the central part of the retina can occur and requires stopping treatment under medical supervision. Other serious risks include new cancers after treatment, including leukemia, myelodysplastic syndromes, non-Hodgkin lymphoma and kidney cancer. Tumor lysis syndrome, a serious complication involving the breakdown of tumor cells, has also been reported. Docetaxel can harm an unborn baby; effective contraception is advised. Its alcohol content may affect the nervous system and impair the ability to drive or use machinery immediately after infusion.
FDA boxed warning
Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2.
Avoid the use of docetaxel injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase > 1.5 x ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel injection.
Do not administer docetaxel injection to patients with neutrophil counts of < 1500 cells/mm 3. Monitor blood counts frequently as neutropenia may be severe and result in infection.
Do not administer docetaxel injection to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel injection infusion and administration of appropriate therapy.
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m 2
Avoid use of docetaxel injection if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle
Do not administer docetaxel injection to patients with neutrophil counts < 1500 cells/mm 3. Obtain frequent blood counts to monitor for neutropenia
Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel injection and administration of appropriate therapy
Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80
Severe fluid retention may occur despite dexamethasone
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Taxotere (docetaxel) if you have a neutrophil count below 1,500 cells/mm³ or a history of a severe allergic reaction to docetaxel or medicines containing polysorbate 80. Severe allergic reactions, including anaphylaxis, have occurred. Docetaxel can harm an unborn baby. Pregnancy status should be checked before treatment, and effective contraception is advised. Do not breastfeed during treatment. Treatment requires monitoring for severe skin reactions, numbness or other altered sensations, nerve pain, severe weakness, and cystoid macular edema (swelling in part of the retina). Some reactions may require treatment adjustment or discontinuation. Monitoring is also needed for later development of certain blood cancers and kidney cancer. Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment. The alcohol content may impair the ability to drive or use machinery immediately after infusion.
Interactions
Medicines that affect the liver enzyme CYP3A4 may change how docetaxel is broken down. CYP3A4 inhibitors can increase docetaxel exposure and should be avoided during treatment. Examples include ketoconazole and protease inhibitors, particularly ritonavir. Tell your doctor about all medicines you take. If a strong CYP3A4 inhibitor cannot be avoided, your doctor may consider closer monitoring for toxic effects and an adjustment to your docetaxel treatment.
Using Taxotere
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] (DailyMed, retrieved 19 September 2026).
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